LB Pharmaceuticals Announces Publication in JAMA Psychiatry of Results from Phase 2 NOVA-1 Trial of LB-102 in Schizophrenia
- Pivotal Phase 3 NOVA-2 trial in schizophrenia ongoing, topline data expected in 2H 2027
- LB-102 has potential to be the first benzamide approved for schizophrenia in the U.S.
NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc ("LB Pharmaceuticals" or the "Company") (NASDAQ:LBRX), a late-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, adjunctive major depressive disorder (MDD), and other neuropsychiatric diseases, today announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial." LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT-7 receptors that is being advanced as a potential first benzamide in the U.S. for the treatment of neuropsychiatric disorders.
"We are pleased to publish the positive results from the Phase 2 NOVA-1 trial in this prestigious, peer-reviewed journal, which we believe underscores the potential for LB-102, if approved, to become an important new treatment option for patients with schizophrenia," commented Anna Eramo, MD, Chief Medical Officer of LB Pharmaceuticals. "Based on LB-102's unique mechanism and these compelling clinical results, we have advanced LB-102 into the pivotal Phase 3 NOVA-2 trial for patients with schizophrenia the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression and plan to initiate a Phase 2 trial in adjunctive MDD in early 2027."
The positive data from the NOVA-1 trial were first announced in early 2025. In this four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB‑102's potential to address multiple domains of neuropsychiatric disease.
LB-102 is currently being evaluated in the pivotal Phase 3 NOVA-2 trial in patients with acute schizophrenia. NOVA-2 is a double-blind placebo-controlled trial that is 6 weeks in duration and designed to enroll approximately 460 patients across 25 sites in the United States. Topline results from NOVA-2 are anticipated in the second half of 2027 and if positive, the Company expects to hold a pre-NDA meeting with FDA thereafter.
About LB-102
LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders. A methylated derivative of amisulpride, a widely used antipsychotic outside the U.S., LB-102 was developed to retain amisulpride's benefits while addressing its limitations. LB-102 is a selective antagonist of D2, D3, and 5HT-7 receptors with few off-target effects and broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB‑102's potential to address multiple domains of neuropsychiatric disease. A Phase 3 clinical trial (NOVA-2) of LB-102 for schizophrenia and a Phase 2 clinical trial (ILLUMINATE-1) of LB-102 for bipolar depression have been initiated, and a Phase 2 trial in adjunctive treatment of MDD is planned. Additional expansion opportunities for LB-102 include predominantly negative symptoms of schizophrenia, Alzheimer's disease psychosis and agitation, as well as other neuropsychiatric diseases.
About LB Pharmaceuticals
LB Pharmaceuticals is a late-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, the adjunctive treatment of MDD, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, adjunctive MDD, and other neuropsychiatric diseases.
Cautionary Note Regarding Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102;and the design, objectives, initiation, timing, progress and results of current and future clinical trials of LB-102, including the Phase 2 NOVA-1 trial, the Phase 3 NOVA-2 trial and the Phase 2 ILLUMINATE-1 trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company's limited operating history and historical losses; the Company's ability to raise additional funding to complete the development and any commercialization of LB-102; the Company's dependence on the success of its lead product candidate, LB-102; the Company's ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company's lead product candidate, LB-102; any undesirable side effects or other properties of the Company's product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company's ability to obtain, maintain and protect its intellectual property; and the Company's dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.
These and other risks are described more fully in the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Media and Investor Contact:
Ellen Rose
erose@lbpharma.us
